Events

Safety Alert for Computed Tomography Fluoroscopic Option Software for Use with the TSX-101A Aquilion and Model TSX-021A Asteion Computed Tomography Scanners: (1) Model TSFX-003A, (2) Model TSFX-003B, (3) Model TSFX-003C

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Toshiba America Medical Systems Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    177
  • Date
    2001-05-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    BRAZIL - 11/21/2001 - THE COMPANY REPORTS THAT THE CORRECTION OF THE PRODUCT WAS OCCURRED BY A BUG OF SOFTWARE RELEVANT TO THE OPTIONAL STUDIED CT FLUOROSCOPY SYSTEM MODEL TSXF-003A, TSXF-003B AND TSFX-003C, THAT MAY BE INCORPORATED IN AQUILION COMPUTERIZED TOMOGRAPHY SYSTEMS TSX-101A AND ASTEION TSX-021A, AND THAT FOR BRAZIL, EQUIPMENT WAS NOT IMPORTED WITH THIS OPTIONAL, BEING EXCLUDED OF CORRECTIVE NECESSARY.
  • Reason
    X-ray generation may occur without command of the operator when an unusual sequence program is used. the importer initiated a recall through correspondence sent on may 10, 2001.
  • Action
    Make sure that you have received the correspondence sent on May 10, 2001 by Toshiba America Medical Systems (TAMS). Follow the instructions given to avoid the above mentioned problem. New software will be distributed August 31, 2001, to correct the problem. For more information, contact TAMS at (800) 421-1968

Device

Computed Tomography Fluoroscopic Option Software for Use with the TSX-101A Aquilion and Model TSX...

Manufacturer

Toshiba America Medical Systems Inc
  • Source
    ANVSANVISA